- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06324279
Cervical Sliding Sign to Predict Outcome of Induction of Labor
The Cervical Sliding Sign as a Marker in Prediction of Successful Induction of Labor
Assess the role of transvaginal ultrasound specifically a sign called cervical sliding sign, in the prediction of success of induction of labor.
The prediction of outcome of induction of labor has always been an important topic to all obstetricians. Bishop score is traditionally considered reliable way to predict the outcome of induction of labor by assessing the cervical dilatation, effacement, position, and consistence and assessing the level of the fetal head in the birth canal. Since The bishop score remains a highly subjective method for prediction of outcome of induction of labor, the use of sonographic measurements such as cervical sliding sign can be a better predictor of successful induction of labor.The presence of CSS was defined as the sliding of the anterior cervical lip on the posterior one under gentle pressure of the transvaginal probe.
Patients undergoing induction of labor with misoprostol will be checked for the cervical sliding sign. The mode of delivery, induction to active labor time and active labor to delivery time will be recorded and analysed to assess whether the sliding sign is an independent predictor of success of induction.
Study Overview
Status
Intervention / Treatment
Detailed Description
Induction of labor is a common practice in modern obstetrics. It is the use of mechanical or pharmacological -or both ways- to stimulate uterine contractions before spontaneous labor to induce cervical dilatation and delivery. Induction of labor at term have many advantages. It can reduce to risk of still birth. It also reduces the risk of macrosomia and its adverse outcomes such as maternal trauma, shoulder dystocia or the need for instrumental delivery (Kim, et al., 2019). However, induction of labor can also have adverse outcomes, the most common is failure and increasing the risk of cesarean section. Induction of labor may not be tolerated by some patients because of the potential increase in the duration of labor or a prolonged latent phase. Increased cost compared to spontaneous delivery course and possible neonatal morbidity if the gestational age is less than 39 weeks of gestation are other drawbacks. (Kim, et al., 2019) Since the success of induction of labor is related to the condition of the cervix, investigators have proposed the importance of having a reliable system for determining the cervical maturity. A number of studies considered the use of sonographic measurement of cervical length to predict the success of labor induction. The sonographic marker for assessing the cervical softening called the cervical sliding sign (CSS) which was introduced by (Volpe, et al., 2019), demonstrated its correlation with the occurrence of impending delivery in women with preterm uterine contractions. The performance of the CSS in predicting the success of IOL was conducted in two academic centers by (Volpe, et al., 2022). However, its generalizability to community hospitals cannot be certain and needs further testing. The presence of CSS was defined as the sliding of the anterior cervical lip on the posterior one under gentle pressure of the transvaginal probe. (Volpe, et al., 2022)
Aim/ Objectives. Assess the role of the cervical sliding sign (CSS) as a marker in the prediction of the outcome of induction of labor (IOL) at term gestation.
Research Hypothesis:
The presence of Cervical Sliding sign in pregnant women at term gestation planned for Induction of labor predicts a higher chance of vaginal delivery within 24 hours.
Research Question:
Is CSS a successful marker for prediction of outcome of induction of labor in pregnant women at term gestation? Methodology
Type of Study: Prospective observational cohort study Study Setting: Ain Shams University Maternity Hospital (labor ward). Study period: 6 months Study Population: The study will be conducted on term pregnant women with Singleton living fetus attending Ain Shams University Maternity Hospital for induction of labor with the following criteria:
Inclusion criteria:
- women age: from 18 to 35 years old.
- Single living term fetus with gestational age ≥ 37 weeks. 3- Eligible for IOL. 4- Bishop score <6 5- Estimated fetal weight < 4Kg.
Exclusion criteria:
- previous caesarean section. (increases risk of rupture uterus)
- Multiple pregnancy, IUFD, preterm or macrosomic fetus (defined as fetus >4.5kg or fetus of diabetic mother >4Kg) (increases risk of shoulder dystocia)
- Women with major uterine anomalies. (appendix A: ESHRE/ESGE classification for Female genital tract anomalies (Grimbizis GF, et al,. 2013) (increases risk of CS)
- Vasa previa, placenta previa (increases risk of antepartum hemorrhage)
- previous myomectomy reaching the endometrial cavity. (Increases risk of rupture uterus)
7- patient refuse to participate or inability to consent. (patient's right to refuse).
Sample Size and sample Size Justification:
Using the PASS 15 program for sample size calculation, reviewing results from a previous study (Volpe et al.2022) showed that the cervical sliding sign (CSS) was found in 48% of the study group (non-consecutive series of uncomplicated singleton term pregnancies, planned for IOL, with a fetus in cephalic presentation patients), based on this frequency and after 20% adjustment for dropout rate, a sample size of at least 130 participants produces a two-sided 95% confidence interval with a width equal to 0.199 when the sample proportion is 0.480.
Ethical Consideration:
This study will be done after approval of the ethical committee of the department of obstetrics and gynecology, faculty of medicine, Ain Shams University. Informed consent will be taken from all participants before recruitment in the study, and after explaining the purpose and procedures of the study. The investigator will obtain the written, signed informed consent of each subject prior to performing any study specific procedures on the subject. The investigator will retain the original signed informed consent form. All laboratory specimens, evaluation forms, reports, video recordings and other records that leave the site will not include unique personal to maintain subject confidentiality. The study will be based on the investigator self-funding.
Study procedures and interventions:
Women fitting into our inclusion criteria will be subjected to:
- history taking (personal, obstetric, medical and surgical)
- Transvaginal ultrasound to assess the presence of CSS with a semi-filled bladder using a 10 MHz endo-vaginal probe EC3-10T of Alpinion E-CUBE 5 ultrasound machine (ALPINION MEDICAL SYSTEMS Co., Ltd. Guro-gu, Seoul, 08393, Republic of Korea) will be done by the most senior resident. "The CSS will be evaluated as follows:
1- acquisition of a sagittal view of the cervix, on which the internal and external os and the endocervical canal could be identified. 2- Gentle pressure with the transvaginal probe on the cervix until maximum compression of the cervix is achieved. 3- Visualization of the anterior cervical lip "sliding" on the posterior one is defined as the presence of CSS." (Volpe, et al., 2022) 3- Induction and management of labor will be conducted following the hospital's protocol (APPENDEX B: FIGO MISOPROSTOL-ONLY RECOMMENDED REGIMENS 2017(Morris JL, et al., 2017)) 4- record the mode of delivery for each participant either vaginal delivery or cesarean deliveries. 5- Measurement of induction-to-active-labor1 time (active labor time defined as ≥ 6cm dilated cervix), active-labor-to-delivery time, total length of labor.
Outcomes:
- 1ry outcome: successful vaginal delivery.
2ry outcomes:
- induction-to-active-labor time interval.
- Active -labor-to-delivery time interval.
- Mode of Delivery (vaginal/ Instrumental/ Cesarean)
- Reason for CS (Fetal distress/ failure of induction/ failure of progress).
Statistical analysis:
- All data will be collected, tabulated, and statistically analyzed by software package program
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11799
- Maternity hospital, ainshams university hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
1. women age: from 18 to 45 years old.
2. Single living term fetus with gestational age ≥ 37 weeks.
3- Eligible for IOL. 4- Bishop score <6 5- Estimated fetal weight < 4Kg.
Exclusion Criteria:
- 1- previous caesarean section. (increases risk of rupture uterus) 2- Multiple pregnancy, IUFD, preterm or macrosomic fetus (defined as fetus
>4.5kg or fetus of diabetic mother >4Kg) (increases risk of shoulder dystocia) 3- Women with major uterine anomalies. (appendix A: ESHRE/ESGE classification for Female genital tract anomalies (Grimbizis GF, et al,. 2013) (increases risk of CS) 4- Vasa previa, placenta previa (increases risk of antepartum hemorrhage) 5- previous myomectomy reaching the endometrial cavity. (Increases risk of rupture uterus) 7- patient refuse to participate or inability to consent. (patient's right to refuse).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
term pregnant women with Singleton living fetus attending for induction of labor
|
Transvaginal ultrasound will be used to see the presence of cervical sliding sign
Induction of labor by misoprostol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mode of delivery
Time Frame: 48 hours
|
Vaginal or cesarean section
|
48 hours
|
Induction to active labor time
Time Frame: 48 hours
|
Start of induction till cervical dilation of 6 cm
|
48 hours
|
Active labor to delivery time
Time Frame: 10 hours
|
From cervical dilation of 6 cm till delivery of fetus
|
10 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Omaima A Mahmoud, mbchb, Ainshams university faculty of medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000017585
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Induction of Labor
-
Holy Family Hospital, Nazareth, IsraelRecruitingInduction of LaborIsrael
-
Kazakhstan's Medical University "KSPH"Asfendiyarov Kazakh National Medical UniversityActive, not recruitingInduction of LaborKazakhstan
-
Sorlandet Hospital HFOstfold Hospital Trust; Haukeland University Hospital; St. Olavs Hospital; Nordlandssykehuset...Completed
-
South Warwickshire NHS Foundation TrustWalsall Healthcare NHS Trust; Medicem InternationalTerminated
-
Cairo UniversityMohamed El Sharkawy; Yomna Bayoumi; mohamed hisham gouda; Dina latifCompleted
-
Christian Medical College and Hospital, Ludhiana...Completed
-
Christiana Care Health ServicesCompletedInduction of LaborUnited States
-
Assistance Publique - Hôpitaux de ParisAgence Nationale de sécurité du MédicamentCompleted
-
Icahn School of Medicine at Mount SinaiCompleted
-
University of California, San FranciscoCompletedInduction of LaborUnited States
Clinical Trials on Transvaginal ultrasound
-
University Hospital MuensterCompleted
-
Washington University School of MedicineNational Cancer Institute (NCI)Completed
-
University of AarhusCompleted
-
Aljazeera HospitalKasr El Aini HospitalUnknown
-
ART Fertility Clinics LLCCompletedEndometrial DiseasesUnited Arab Emirates
-
Intermountain Women and Children's ResearchUnknownCervical InsufficiencyUnited States
-
Semmelweis UniversityCharles University, Czech Republic; Jagiellonian University; St John of God Hospital...Not yet recruitingEndometriosis | Radiculopathy | Nerve Sheath TumorHungary
-
ChaingMai UniversityWithdrawnPreterm Delivery Within 7 Day After AdmissionThailand
-
Dina Mohamed Refaat DakhlyCompleted
-
Hadassah Medical OrganizationUnknownIn Vitro FertilizationIsrael